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Focus on Service:
LifeNet Health Meets ASTM Standards for Shipping and Validation
 As the world’s most trusted provider of bio-implants and organs for transplantation, LifeNet Health distributes more than 300,000 bio-implants each year to meet the urgent needs of hospitals and patients around the country. Our perfect safety record is due in part to our validated storage and shipping methods. Precise storage, packaging and shipping requirements exist for each specific bio-implant type. LifeNet Health follows those guidelines and provides detailed instructions for safe storage and preservation of shipped products at a medical facility.
Packaging, shipping and receiving guidelines for LifeNet Health’s freeze-dried/Preservon® and frozen bio-implant products.
Freeze-dried and Preservon® Products
Packaging: The packaging for LifeNet Health’s freeze-dried and Preservon® bio-implants has been validated to ASTM standards to maintain their integrity during recommended standard shipping procedures. Freeze-dried and Preservon® bio-implants are packaged in validated packaging that allows for shipping under standard shipping conditions. Studies have shown that under normal shipping conditions the temperature and integrity of freeze-dried tissue products and its packaging remain stable. The testing of product packaging encompassed extreme upper and lower limits of temperatures from –40°C (–40°F) to 50°C (120°F) during summer and winter conditions.
Shipping: When shipping freeze-dried and Preservon® bio-implants to hospitals, LifeNet Health contracts with UPS as its main carrier, utilizing overnight or second day shipping services. Shipments are tracked daily and customers are notified in a timely manner of any delays in delivery. LifeNet Health’s shipping container for freeze-dried bio-implants is a corrugated box with protective filler material added as required by the product type.
Receiving: LifeNet Health’s bio-implant integrity is maintained if the external and internal packaging has not been compromised and the defined standard shipping procedures have been met. It is not necessary to monitor the temperatures within the package upon receipt. The receiving personnel at the medical facility must check the integrity of the external shipping container for damage and check the integrity of the internal bio-implant package to ensure, for example, that all seals are intact, the packaging has no cracks or punctures, and there has been no loss of vacuum, as applicable. The receipt information must be documented.
Frozen Bio-Implant Products
Packaging: The packaging for LifeNet Health’s frozen bio-implants has been validated to ASTM standards to maintain their integrity during recommended standard shipping procedures.
Shipping: When shipping frozen bio-implants to hospitals, LifeNet Health contracts with UPS as its main carrier, utilizing overnight shipping services. Shipments are tracked daily and customers are notified in a timely manner of any delays in delivery. The insulated shipping containers for frozen bio-implants have been validated to maintain temperatures required to preserve product integrity. The expiration time and date specific for each shipment is recorded on the outside of the shipping container.
Receiving: Upon receipt of LifeNet Health’s frozen bio-implants, the receiving staff at the medical facility must document that the shipping container was not damaged during shipment, there is refrigerant remaining in the shipping container, and the shipment arrived by the time and date recorded on the outside of the shipping container. An inspection of the packaging of each individual bio-implant must also be performed to verify and document that the integrity of the individual tissue package was maintained during shipping. Visual inspection of the packaging should ensure, for example, that that all seals are intact, the packaging has no cracks or punctures, and there has been no loss of vacuum, as applicable.
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